AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
Hazard
Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
What You Should Do
Remedy
AmniSure notified users by Medical Device Correction (Recall) letter dated October 1, 2007 issued via US Mail. The letter provides additional labeling instructions and a checklist for trouble shooting, including a diluation procedure that allows users to determine and solve the problem of the hook effect with this device.
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Products
AmniSure ROM Test, Fetal Membrane Rupture Test for
In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
- Brand
- AmniSure International LLC
- UPC
- Lot Number/ Exp. Date A7003, 01/2009. A7002, 11/2008, A7001, 10/2008, A6005, 04/2008, A6004, 01/2008, A6003, 09/2007, and A6002-3, 09/2007
Units Affected
319,976 units